Post-Market Clinical Follow-Up onTVT EXACT® Continence System

Eligibility Criteria

• 1. Stress urinary incontinence symptoms
• 2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
• 3. Female subjects ≥ 21 years of age requiring treatment of SUI
• 4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
• 5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
• 6. Patient able and willing to participate in follow-up
• 7. Subject or authorized representative has signed the approved informed consent
• 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
• 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
• 3. History of previous synthetic, biologic or fascial pubo-urethral sling
• 4. Pregnancy or plans for future pregnancy
• 5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
• 6. Current genitourinary fistula or urethral diverticulum
• 7. Reversible cause of incontinence (i.e. drug effect)
• 8. Contraindication to surgery